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Long-Term Results of Bone Cement in Stapes Surgery

Evaluation of Long-Term Results of Bone Cement Application in Stapes Surgery and Factors Effective on Results in Stapes Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06221007
Enrollment
73
Registered
2024-01-24
Start date
2024-08-01
Completion date
2024-12-01
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Keywords

stapedotomy, otosclerosis

Brief summary

Considering the long-term results of otosclerosis surgery performed in our clinic, it was observed that in addition to the improvement in air conduction hearing, which indicates conductive hearing, which is the main success of the surgery, there was also an improvement in bone conduction hearing, which indicates sensorineural hearing, in patients using bone cement. Our study aimed to examine the effect of bone cement use in otosclerosis surgery on long-term hearing thresholds and bone conduction.

Detailed description

A retrospective review was conducted on records of patients who underwent stapes surgery between 2012 and 2020. Comprehensive records were selected, and patients were summoned for clinic visits for thorough examinations. Evaluation encompassed the average of air and bone conduction at 500, 1000, 2000, and 4000 Hz. A procedure-specific 16-item questionnaire and the Glasgow Benefit Inventory (GBI) were used for perceived benefit and effective factors.

Interventions

PROCEDUREUse of bone cement in otosclerosis surgery

Surgical technique; It involves separating the sclerosed stapes from the oval window and incus under an endoscope or microscope and replacing it with a Teflon piston, which is a middle ear prosthesis. In this way, a new connection between the incus and the oval window ensures the transmission of sound to the inner ear. Bone cement has long been used in primary and revision ossiculoplasty, including stapedotomy of the middle ear. During stapedotomy, the part of the Teflon piston that places the teflon piston on the incus is fixed with bone cement, aiming to keep the prosthesis in place for a long time and prophylactic treatment of incus necrosis.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis

Exclusion criteria

* Inadequate information in files

Design outcomes

Primary

MeasureTime frameDescription
Incidence of improvement of conductive hearing loss in patients using bone cementThis retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022Changes in conductive hearing loss will be examined using pure tone audiometry testing.

Secondary

MeasureTime frameDescription
Incidence of decrease in bone conduction hearing threshold in patients using bone cementThis retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022The change in sensorineural hearing threshold will be examined using pure tone audiometry test.
Glasgow Benefit inventoryThis retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 2022The GBI is an 18-item, validated instrument designed specifically to assess patient-perceived benefits following otolaryngologic interventions. It utilizes a five-point Likert scale. The score is changing between -100(worst) and +100(best). Total scores interpreted as follows: \>50 indicates significant benefit, 10-50 indicates moderate benefit, and \<10 denotes no perceived benefit.
Postoperative questinarieThis retrospective cohort study with prospective follow-up included patients who underwent stapes surgery for conductive hearing loss between 2012 and 202216 items stapedotomy specific questions

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFazıl N Ardıç, MD

Pamukkale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026